Bioequivalence and Bioavailability Forum • Teriminal partial AUC for Metformin ER Tablets

Teriminal partial AUC for Metformin ER Tablets [Regulatives / Guidelines]

posted by Naveen Kumar – India, 2014-09-11 08:15 (4311 d 11:54 ago) – Posting: # 13481
Views: 3,988

Hi,

Thank you for the prompt response, yes it is a generic product, intended submission is for European Uninon.

As per "Guideline on the pharmacokinetic and clinical evaluation 4 of modified release dosage forms" EMEA, 21 February 2013

lines 797-800 states that

Bioequivalence should be demonstrated by showing equivalence after statistical evaluation of the following parameters:

Single dose: AUC(0-t), AUC(0-∞), Cmax, partialAUC

Please comment, it is not necessary to calculate Partial AUCs for generics (as per your Quote)?

Regards,
Naveen Kumar.SR

Complete thread:

Teriminal partial AUC for Metformin ER Tablets Naveen Kumar 2014-09-10 12:34 [Regulatives / Guidelines]
- Teriminal partial AUC for Metformin ER Tablets jag009 2014-09-10 19:51
  - Teriminal partial AUC for Metformin ER TabletsNaveen Kumar 2014-09-11 06:15
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